Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Alphamab, CSPC, Nrx, Oncolyze, Oncotelic, Oncternal, Samsung, Simcere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Alnylam, Biomea, Biomérieux, Cantabio, Clear Creek, Eisai, Exelixis, Genevant, ICER, Iconic, Liscure, Lqt, Novartis, Novo, Noxxon, Plus, Rain, Roche, Roivant.
The epic rise and fall of Elizabeth Holmes, founder of Theranos Inc., will preoccupy the world of business for decades to come, but this story has also left a large footprint in the world of clinical diagnostics. David Stein, CEO of Babson Diagnostics Inc., of Austin, Texas, told BioWorld that investors are a bit more wary than usual because of the Theranos saga, forcing test developers to be more rigorous in test development and more transparent with investors about a test.